1、Unit 41 .unwanted effects 非預(yù)期的反應(yīng)2 .normal therapeutic doses 常規(guī)治療劑量3 .mimics 相似4 .diverse clinical signs and symptom* 種臨床癥狀和體征5 .type A and type B A 型和 B 型6 .pharmacological effect 藥理作用7 .low therapeutic index 低治療指數(shù)8 .Predictable 預(yù)測9 .dose-related 劑量相關(guān)10 .erious or even fatal 嚴(yán)重的甚至致命11 .intracranial

2、bleeding 顱內(nèi)出血12 . incorrect dosage 不適量給藥13 .disordered pharmacokinetics 代謝紊亂14.impaired drug elimination 消除不正常15.side-effects 副作用16 .Pharmacodynamics藥效學(xué)17 .Pharmacokinetics 藥動學(xué)18.1 diosyncratic 特異性反應(yīng)19. Pathophysiology 病理生理學(xué)20.genetic or immunological 遺傳學(xué)和免疫學(xué)21.occur infrequently 發(fā)生率較低22 .continuous

3、 reactions 持續(xù)反應(yīng)23 .long-term drug use 長期用藥24 . delayed reactions 延遲反應(yīng)25 .alkylating agents leading to carcinogenesis 烷化劑致癌26 .Teratogenesis 致畸27 .end-of-use reactions：停藥反應(yīng)28 . withdrawal syndromes：w?e?dr?:?l's?ndr?mz 戒斷-綜合征29 .discontinuation： ?d?sk?n?t ?nj?'e?n 停止30 .antidepressants ：抗抑郁31

4、. depressants： d?p?resnt 鎮(zhèn)靜劑32 .Fatalities 死亡時間33 .fatality-fatalities:f ? l?ti死亡34 .hepatic or renal disease 肝腎疾病35 .surveillance pharmacovigilance36 .high degree of sensitivity and specificity 高度的敏感性和針對性37 .detect rare but severe 罕見但嚴(yán)重38 .the incidence of 發(fā)生率39 .predisposing factors 易感因素40 .Quanti

5、fy 量化41 .Continued surveillance is mandatory 持續(xù)性監(jiān)測42 .many ill effects 副作用43 .uncommon adverse effects 罕見不良反應(yīng)44 .assessing the tolerability and dose-response relationship of new therapeutic agents!藥的耐受性和量效關(guān)系45 .serious toxicity 嚴(yán)重的毒性46 .the incidence of common adverse reactions般不良反應(yīng)的發(fā)生率47 .dropping

6、out 撤出48 .resembles spontaneous disease 原患疾病的表現(xiàn)相似49 .Magnitude 數(shù)量級Unit 61 .A natural product is a chemical compound or substance produced by a living organism - found in nature that usually has a pharmacological or biological activity for use in pharmaceutical drug discovery and drug design. A natur

7、al product can be considered as such even if it can be prepared by total synthesis. 天然產(chǎn)物是指活的有機(jī)體產(chǎn)生的化合物或物質(zhì)，在天然條件下通常有一定藥理或生物活性，它用于藥物研發(fā)和藥物設(shè)計(jì)。盡管天然產(chǎn)物可以通過全合成來制備，人們?nèi)钥烧J(rèn)定其天然屬性。2 .Natural Product:：天然產(chǎn)物；3.5.Drug discovery藥物研發(fā);4.6.Total synthesi除合成；5.high throughput screening(HTS)6.LC-MS 液質(zhì)聯(lián)用7.7.LC-NMR 液相色譜-核磁共振

8、聯(lián)用1.1. igh throughput screening(HTS)高通量篩選1.2. igh throughput screening(HTS)高通量篩選10 . LC-MS 液相色譜-質(zhì)譜聯(lián)用11 .LC-NMR 液相色譜-核磁共振聯(lián)用Unit 712 drug delivery 藥物給藥系統(tǒng)13 peak-and-trough 波峰-波谷14 constant concentrations of drugs 穩(wěn)定的藥物濃度15 Sustained-release technology 緩釋技術(shù)5 .controlled-release delivery system 控制釋放給藥系統(tǒng)

9、6 .Nonoral 非口服7 .at a constant rate 穩(wěn)定的速度8 .The plethora of preparations 控釋技術(shù)9 .water-soluble drug 水溶性的藥物10.large molecules 逃離迷宮11 .drug-containing complex 含有藥物的復(fù)合體12 .positive electric charge 用電離子滲透法13 .pill pump 滲透泵片14 .semipermeable membrane 半透膜15 .osmotic pressure 滲透壓16 .The rate of drug deliver

10、y 給藥速度17 .liver cancer drugs 肝癌藥物18.delivery rate 運(yùn)輸速率19.at a constant rate 固定速度20.particle size. 顆粒的大小21.liver and lungs 肝臟和肺部22.systemic toxicity 全身性毒性23 .monoclonal antibodies 單克隆抗體24 .in the concept stage. 處于概念階段25 .computer-guided drug dosing 計(jì)算機(jī)指導(dǎo)制定藥物劑量26 .computer-aided diagnosis 計(jì)算機(jī)輔助診斷27 .T

11、ransmucosal Delivery28 .Osmotic Devices29 .Respiratory Delivery30 .LiposomesUnit 81. By utilizing the methodologies and techniques in physics, chemistry, biology and microbiology, pharmaceutical analysis focuses on qualitative and quantitative analysis of drugs, quality control and development of ne

12、w drugs它運(yùn)用物理學(xué)、化學(xué)、物理化學(xué)、生物學(xué)和微生物學(xué)等的方法和技術(shù)研究藥物的定性和定量分析、藥物的質(zhì)量控制和新藥開發(fā)。2. A selective reaction or test is one that can occur with other substances but exhibits a degree of preference for the substance of interes璉擇性反應(yīng)或鑒別是指可以和其他物質(zhì)發(fā)生反應(yīng)但對敏感物質(zhì)顯示一定程度偏好。3. A specific reaction or test is one that occurs only with t

13、he substance of interest.屬性反應(yīng)或鑒別是指僅與敏感物質(zhì)發(fā)生反應(yīng)。Unit 101 .Drug standard usually includes official name, description, identification, purity test, content (potency or activity) assay, dosage, strength, storage and preparation etc.因此，藥品標(biāo)準(zhǔn)一般包括以下內(nèi)容：法定名稱、性狀、鑒別、純度檢查、含量(效價或活性)測定、劑量、規(guī)格、貯藏、制劑等等。2 .Some importan

14、t pharmacopeias includes United States Pharmacopoeia/National Formulary, British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia.現(xiàn)在世界上主要藥典有：美國藥典/國家處方集、英國藥典、歐洲藥典、日本藥局方。3 .The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Huma

15、n Use (ICH) 人用藥物注冊技術(shù)要求國際協(xié)調(diào)會4 .The United States Pharmacopoeia (USP) the National Formulary (NF) 美國藥典/國家處方集Unit 141 .Health and Human Services 美國人類健康服務(wù)部(HHS)2 .federal executive departments 聯(lián)邦行政機(jī)構(gòu)3 .protect and promote:保護(hù)和促進(jìn)4 .regulation and supervision管理和監(jiān)督5 .Public Health Service Act 公共健康法案6 .sanit

16、ation n. 環(huán)境衛(wèi)生7 .no drug is absolutely safe沒有任何藥品是絕對安全的8 .some risk of an adverse reaction 發(fā)生藥品不良反應(yīng)的風(fēng)險9 .t s when the benefits outweigh the risks that FDA considers a drug safe enough to approve. 只有當(dāng)收益大于風(fēng)險時美國FDA才會認(rèn)定該藥足夠安全，可以批準(zhǔn)。10 .Pre-market safety approval of all new drugs藥品上市前的安全性證明11 .Premarket ef

17、ficacy and safety 藥品上市前安全性和有效性證明12 .the idea of risk vs. benefit that is now the key to new drug approval. 這一思想現(xiàn)在成為了 新藥審批的關(guān)鍵13 .Providing evidence of safety before marketing was first required by the Federal Food, Drug and Cosmetic Act in 1938, but not until the Drug Amendments of 1962 did firms als

18、o have to show a drug' s effectiveness before marketing. 1938年的 FDCA法案開始要求藥品上市前必 須證明其安全性，但是直到1962 藥品修正案才要求藥品上市前也要提供證明其有效性。14 .a thorough evaluation 全面的評估15 .ntended use 預(yù)期作用16 .broader use 更廣泛的使用17 .desperately ill and dying patients 垂危病人18 .Promising is the key word in this broadened use of una

19、pproved drugs擴(kuò)大使用未被批準(zhǔn) 藥物的關(guān)鍵是這些藥“有前途”19 .A "try anything"approach 任何均可嘗試的方法20 .FDA requires that experimental drugs, too, satisfy a certain benefit-to-risk ratio.FDA1求實(shí) 驗(yàn)性藥物同樣要滿足一定的風(fēng)險效益比。1.1 Investigational New Drug Application IND 試驗(yàn)用新藥申請/臨床試驗(yàn)申請22 .New Drug ApplicationNDA 新藥申請23 . A drug i

20、s first reviewed, however, when a sponsor submits an investigational new drug application (IND) to FDA before tests with people begin責(zé)任人要首先向 FDA 提交新藥臨床試 驗(yàn)申請(IND) ，審評后方可開展人體試驗(yàn)。24 .f so, the IND is considered to be“ in effect” and the clinical study may proceed; if not, FDA may place the study on hold

21、 until the sponsor makes needed changes口果是，新藥臨床研究 申請被認(rèn)為有效，臨床試驗(yàn)可以開展。如果不是，F(xiàn)DA則會擱置該申請，直到申請者提供必要的改進(jìn)。25 .Sponsors are encouraged to meet with FDA before the final phase of human tests, which are the large-scale controlled clinical trials. At this conference, FDA gives advice about the design ofthe sponso

22、r* s study plan to ensure that the trials will be acceptable. FD般勵責(zé)任人在開展最 后一期大規(guī)模臨床對照試驗(yàn)前與其會晤。在這次會晤上，F(xiàn)DA會對申請者的試驗(yàn)方案給予意見，以保證臨床試驗(yàn)可被許可。26 .Review Time 審批時間27 .an average of 10 to 18 months less time 一般少于10 到 18 個月28 .averaged just 131/2 months 平均只用了13.5 個月的時間29 .A Reviewer's Day 審評員的一天30 .four NDAs 4份

23、新藥申請31.only about 60 percent of a reviewer s time is actually spent reviewing 此外，審評員只有60%的時間真正花在審評上。32 .the basis of FDA s evaluation of safety and effectiveness.它是 FDA評估其安全性和有效 性的基礎(chǔ)。33 .they help to clarify the drug's benefit-to-risk relationship有助于明確該藥的風(fēng)險效益關(guān)系34 .drug' s professional labeli

24、ng藥專業(yè)說明書上的信息35 . a classification system.分類系統(tǒng)36 . As FDA resources are limited, the idea is to give priority to drugs with the greatest potential benefit.FDA資源優(yōu)先，因此其思想是將優(yōu)先權(quán)給予具有最大潛在效益的藥物。 37. a significant medical advance over existing therapies for any other disease.次在治療其 他疾病上比現(xiàn)有藥物有重大突破的藥物。38 .When

25、an important new drug is about to be approved, a “ Summary Basis for Approva” l is written, laying out FDA' s basis for deciding the drug is safe and effective 當(dāng) 個重要的新藥 快被通過審批時，需要起草一份“藥物批準(zhǔn)概要依據(jù)”來陳述FDA認(rèn)定該藥安全有效的依據(jù)39 .FDA staff may visit the sites of some of the studies to compare results provided in